LEGAL FRAMEWORK

The commercialization and use of cannabis products in Perú are strictly regulated by a legal framework that ensures their production, distribution, and consumption are conducted safely and responsibly. This section outlines the current regulations, including Law N° 30681, which governs the medicinal and therapeutic use of cannabis and its derivatives, as well as its current regulation, Supreme Decree N° 004-2023-SA. It also references provisions related to controlled substances and the obligations applicable to licensed pharmacies offering these products and our operations:

• Law N° 26842, General Health Law.

• Law N° 30681, Law regulating the medicinal and therapeutic use of Cannabis and its derivatives, its amendment, and the current regulation (Supreme Decree N° 004-2023-SA).

• Regulations on Narcotics, Psychotropic Substances, and other substances subject to sanitary control, approved by Supreme Decree N° 023-2001-SA, and its amendments. 

• Legislative Decree N° 1241, Law for Strengthening the Fight Against Illicit Drug Trafficking and its Regulations. 

• Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol. 

• United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988. 

• Pharmaceutical Establishments Regulation, approved by Supreme Decree N° 014-2011-SA, and its amendments. 

• Regulation for the Registration, Control, and Sanitary Surveillance of Pharmaceutical Products, Medical Devices, and Sanitary Products, approved by Supreme Decree N° 016-2011-SA, and its amendments. 

• Regulation for the Registration, Control, and Sanitary Surveillance of Pharmaceutical Products and Related Products, approved by Supreme Decree N° 010-97-SA, and its amendments. 

• NTS N° 123-MINSA/DIGEMIDV.01: Technical Health Standard regulating Pharmacovigilance and Technovigilance activities for Pharmaceutical Products, Medical Devices, and Sanitary Products, approved by Ministerial Resolution N° 539-2016/MINSA, or its successor.

• Law N° 29571, Consumer Protection and Defense Code, and its amendments.

• Law N° 29733, Law on Personal Data Protection, and its amendments.

• Consolidated Text of Law N° 27444, Law on General Administrative Procedure, approved by Supreme Decree N° 004-2019-JUS.

• Law N° 27262, General Seed Law, and its amendments.  

• Law N° 27446, Law on the National Environmental Impact Assessment System, its Regulations, and related phytosanitary and analogous regulations.

• Legislative Decree N° 1278, Legislative Decree approving the Law on Comprehensive Management of Solid Waste, its amendments, and its Regulation approved by Supreme Decree N° 014-2017-MINAM.